Washington, DC — Today, over 50 patient, senior citizen, global health, development, social justice, and faith groups urged the United States Government to use its rights in a federally funded patented invention, and accept the request by a Canadian generic drug manufacturer (Biolyse Pharma) to enter into an agreement to manufacture and export an affordable version of the taxpayer-funded prostate cancer drug enzalutamide to South Africa and other countries with low per-capita incomes relative to the United States.

Enzalutamide, more commonly known by its trade name Xtandi, was developed at the University of California, Los Angeles (UCLA) with grant support from the National Institutes of Health and the U.S. Army. Astellas Pharma and Medivation market Xtandi worldwide, under a license from the University of California.

The United States government has a royalty-free “license to practice or have practiced for or on behalf of the United States” the patents on Xtandi “throughout the world” [see 35 U.S.C. §202(c)(4) and the Additional Information below]. The federal government’s license to use the patents on Xtandi is a safeguard that can be used to ensure that the drug is available to the public at affordable prices.

In a September 28, 2016 letter to the Department of Health and Human Services (DHHS), the Canadian generic drug manufacturer, Biolyse Pharma, asked to enter into an agreement that would allow the company to make and supply enzalutamide at an affordable price to prostate cancer patients in countries with less than one-third of the per capita income of the United States, where the high price of the drug presents a significant barrier to access for patients in need.

Organizations from Angola, Brazil, Chile, Colombia, India, Kenya, Malaysia, and South Africa signed the letter to Health and Human Services Secretary Sylvia Mathews Burwell, as well as groups from across the U.S. and Europe. The letter concludes with a reminder that the United States government has the power to enable or deny access to this drug:

“Poor access and outcomes can be portrayed as a consequence of market failures, but in this case, the market failures would be a consequence of policy failures. The barriers to more equal access would correctly be perceived as a lack of concern about patients in developing countries, for a disease that disproportionately kills people of African descent.

“Having advanced prostate cancer is a personal tragedy. It is a different type of tragedy when a government rejects requests to make affordable cancer drugs available.”

“Often neglected in the U.S. drug pricing debate is the power the government has to protect the public from excessive prices for drugs that were developed with federal research funding. While some might accept that the United States will tolerate excessively high domestic prices on a federally funded invention, it is an entirely different matter to ignore the consequences of high prices in countries where incomes are far lower. The Biosyle offer cannot succeed unless the U.S. government wants it to succeed. Poor people in developing countries do not have any legal rights to patents funded by the NIH or the Army. But these are people, living with cancer, and we should not turn our backs on their needs. No one should pretend this is a decision to be made by Pfizer or Astellas. The decision will be made by our government, the people we elect to represent our values.”

Paul Davis, Knowledge Ecology International:

“U.S. taxpayers funded the invention of enzalutamide. It is unacceptable for a crucial medicine to be kept out of the hands of desperate patients in impoverished countries when the U.S. government holds royalty-free rights. Francis Collins, the current head of the NIH has been irresponsibly unwilling to exercise the rights he has under existing law to protect the public at home and abroad from deadly price-gouging by drug companies like Astellas. It will be a deadly disappointment if Health Secretary Burwell lacks the spine to step in and make this drug available.”

Fran Quigley, People of Faith for Access to Medicines, +1-317-750-4891, http://pfamrx.org:

“People of all faith and moral traditions agree that it is unacceptable for sick persons to be blocked from accessing lifesaving medicines because of high prices artificially propped up by government-granted monopolies. It is not just our U.S. leaders’ legal right to make this publicly-funded cancer medicine available to all those in need, it is their moral obligation.”

“Prostate cancer is the second leading cancer in men worldwide, and rates are rising quickly in emerging economies, where access to treatment is poor and mortality rates disproportionately high. Astellas is charging an excessive price for Xtandi (enzalutamide), a drug developed with funding from the U.S. Government — but the USG can now choose to be a part of the solution, by entering into an agreement with generic manufacturer Biolyse Pharma to manufacture a more affordable generic version for export and sale in low- and middle-income countries.

“Poor access and outcomes are often dismissed as an inevitable consequence of market failure, but here market failure would be a direct result of policy inaction. The United States Government can and should take this opportunity to use its rights to an invention it has funded to support expanded access in developing countries.”

“Social Security Watch represents seniors and others on fixed incomes who are done being quiet about astronomical drug prices in the United States of America, and the flaws in the global marketplace for drugs. When U.S. taxpayers pay for the R&D to invent a drug, we don't expect the prices to be excessive, and we don't expect access barriers for poor people living in developing countries. We support all efforts to eliminate excessive drug prices, and in particular when prices create unnecessary and health threatening barriers for access.”

Xtandi’s Market
Xtandi is sold in the United States at a price of over $129,000 per year, by two drug companies: California-based Medivation, which has a licensing deal on the drug with UCLA, and Japan-based Astellas.

Prostate Cancer
Worldwide, around 1.1 million men were diagnosed with prostate cancer in 2012, with around 353 diagnoses in less developed countries. Globally, prostate cancer caused 307 thousand deaths in 2012. Prostate cancer disproportionately affects men of African descent regardless of nation or income, with a mortality and incidence of almost double white men in the U.S.

Bayh-Dole Act Royalty Free License
35 U.S.C. § 202(c)(4) provides for a worldwide “nonexclusive, nontransferrable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States” any patented invention that directly resulted from research that was funded by the federal government. Biolyse asked the government to use its license to allow Biolyse to manufacture Xtandi on behalf of the United States for export to countries with low incomes.

For more information on the difference between the § 202(c)(4) right and other federal authorities to end monopolies on patented pharmaceuticals, see http://keionline.org/node/2633.

Biolyse Pharma
Biolyse is a Canadian generic drug manufacturer. They supply 80-percent of the Canadian market of the important cancer drug paclitaxel. For more, see http://biolyse.com.

We are writing to ask that the United States Government use its rights to inventions it funded to expand access to patented cancer drugs in developing countries. We are specifically urging you to respond favorably to the September 28, 2016 request by the Canadian company Biolyse Pharma regarding the patents on the cancer drug, enzalutamide, now sold worldwide by the Japanese corporation Astellas at very high prices under the brand name Xtandi.

The United States Government is by far the largest investor worldwide in biomedical research, with more than US$30 billion spent last year by the U.S. National Institutes of Health alone. As organizations and individuals worldwide who support health and equity, we are grateful to the United States–and American taxpayers–for contributions towards better health for all.

Prostate cancer is the second leading cancer in men worldwide, and rates are rising quickly in emerging economies. In sub-Saharan Africa, even countries with low incidences face severe and disproportionate mortality rates.

Astellas is charging an excessive price for Xtandi, even though the drug was invented and developed with funding from the NIH and the U.S. Army. In this case, the United States Government can either be a part of the solution — or, by choosing inaction, to be a part of the problem. As with all inventions developed with U.S. Government funding, the United States retains the right to have the inventions be “practiced throughout the world by or on behalf of the Government of the United States,” pursuant to 35 U.S.C. § 202(c)(4).

The Canadian generic manufacturer Biolyse Pharma has asked DHHS to enter into an agreement that would enable Biolyse to manufacture a more affordable generic version of enzalutamide for export and sale in low- and middle-income countries.

If the U.S. Government enters into an agreement with Biolyse or other generic drug manufacturers, this important cancer medicine will be far less expensive and far more widely accessible. If the U.S. ignores or rejects the request, and no agreement is forthcoming, access to the prostate cancer will be restricted, and unequal. It is appalling to have restrictions on access to a publicly funded cancer drug, and it is morally repugnant to deliberately sanction unequal access.

Poor access and outcomes can be portrayed as a consequence of market failures, but in this case, the market failures would be a consequence of policy failures. The barriers to more equal access would correctly be perceived as a lack of concern about patients in developing countries, for a disease that disproportionately kills people of African descent.

Having advanced prostate cancer is a personal tragedy. It is a different type of tragedy when a government rejects requests to make affordable cancer drugs available.

We urge you to seize the moment and take leadership that creates new opportunities for treatment for patients who are now excluded from the benefits on advances in treatment for this cancer.